Actively Recruiting
Double Simultaneous Uterotonic Agents (Misoprostol Plus Intravenous Oxytocin) Versus Single Agent Regimen (Intravenous Oxytocin Only) to Prevent Early Postpartum Hemorrhage
Led by Stony Brook University · Updated on 2025-05-04
1358
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether using two medications at the same time, misoprostol and oxytocin, is more effective than using only oxytocin in preventing early postpartum hemorrhage, which is heavy bleeding after childbirth. This bleeding is a leading cause of maternal illness and death worldwide. The study aims to find out if the combination reduces blood loss better and to identify any side effects compared to the standard single medication treatment. Participants will be randomly assigned to one of two groups. One group will receive the standard care of intravenous oxytocin after delivery, while the other group will receive both oxytocin intravenously and misoprostol given under the tongue at the same time. This approach is designed to test the effectiveness and safety of the double medication regimen during the critical period after childbirth. During the study, researchers will measure the amount of blood lost after delivery to compare the two treatment groups. They will also monitor for any serious side effects recorded in medical records. The study is expected to last about one year from the start of participant enrollment, with ongoing observations and data collection throughout that time.
CONDITIONS
Brief Title
Double Simultaneous Uterotonic Agents Versus Single Agent Regimen to Prevent Early Postpartum Hemorrhage
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women 18 years and older admitted for delivery at Stony Brook University hospital
- Agree to participate in the study
You will not qualify if you...
- Women under 18 years old
- Known coagulation disorders
- Planned cesarean hysterectomy
- Known placental accreta spectrum disorders
- Known allergy to prostaglandins
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - During the immediate postpartum period
Participants receive postpartum uterotonic agents to prevent early postpartum hemorrhage. They are assigned to receive either intravenous oxytocin alone or a combination of sublingual misoprostol and intravenous oxytocin administered simultaneously.
1 treatment visit at delivery (in-person)
Duration - Up to 1 year after delivery
Participants are monitored for safety and outcomes related to postpartum hemorrhage and any adverse effects from the uterotonic agents.
Periodic follow-up assessments as documented during routine care
Trial Site Locations
Total: 1 location
1
Stony Brook University
Stony Brook, New York, United States, 11794
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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